When to INDuce for OverWeight? (WINDOW)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Aarhus
About this trial
The rate of overweight and obese women becoming pregnant is increasing. Obesity in pregnancy along with delivery by cesarean section in obese women is associated with several complications as compared to normal weight women. The longer the woman is pregnant, the longer she is at risk. In an otherwise low-risk pregnant woman at term, it is an ongoing clinical dilemma, whether the benefits of elective induction of labor and termination of the pregnancy will outweigh the potential harms from concomitant induction and delivery process. The proposed study is a randomized controlled study of elective induction versus expectant management in obese women. The study will be carried out as a national multicenter study with inclusion of 1900 participants from Danish delivery wards. The null hypothesis is that the caesarean section rate is similar with elective induction of labor at 39 weeks of gestation, compared with expectant management among pregnant women with pre- or early pregnancy BMI≥30.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Legal or ethical considerations: maternal age <18 years, language difficulties requiring an interpreter or translator
Multiple pregnancy
Previous caesarean section
Uncertain gestational age, defined as gestational age determined by other measurements than the Crown-Rump length (CRL) Measurement
Trial design
Design model
Parallel
Treatments tested in this trial
Elective induction of labor at 39 gestational weeks and 0 to 3 days
Procedure/SurgeryElective induction of labor (eIOL) according to local policies
Treatment groups
1,900 Participants
are divided into 2 treatment groupsGroup A: Elective induction of labourExperimental treatment 1 intervention
Group B: Expectant managementNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Caesarean section
number (no.)
Time frame
At deliverySecondary outcomes
1
Mode of delivery if not by caesarean
* Vaginal delivery - no. * Vaginal assisted delivery - no.
Time frame
At delivery2
Mode of delivery
* Caesarean section - percent * Vaginal delivery - percent * Vaginal assisted delivery - percent
Time frame
At delivery3
Vaginal assisted delivery
* Forceps - no. * Ventouse - no.
Time frame
At delivery4
Indication for caesarean section (more than one indication is possible)
* Labour dystocia - no. * Fetal distress - no. * Maternal request - no. * Suspected macrosomia - no. * Non-cephalic presentation - no. * Extensive vaginal bleeding - no. * Suspected uterine rupture - no. * Maternal or fetal complication/condition (free text) - no. * Other indication for caesarean section (free text) - no.
Time frame
At deliveryOther outcomes
1
Neonatal characteristics 1
* Female sex - no. * Birth weight \> 4500 grams (y/n) - no.
Time frame
At delivery2
Neonatal characteristics 2
\- Mean birth weight - grams
Time frame
At delivery3
Maternal experience on birth
Childbirth Experience Questionnaire Scoring range is 1 to 4 where higher ratings reflect more positive experiences
Time frame
4-6 weeks postpartum4
Maternal postnatal depression
* Major Depression Inventory (MDI) * Edinburgh Postnatal Depression Score Scoring range is 1 to 4 where higher ratings reflect more positive experiences
Time frame
4-6 weeks postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
Aarhus University Hospital
Collaborator
Randers Regional Hospital
Collaborator
Herning Hospital
Collaborator
Central Jutland Regional Hospital
Collaborator
Nykøbing Falster County Hospital
Collaborator
Odense University Hospital
Collaborator
Rigshospitalet Juliane Marie Centret
Collaborator
Kolding Sygehus
Collaborator
Herlev Hospital
Collaborator
Hvidovre University Hospital
Collaborator
North Zealand's Hospital
Collaborator
Zealand University Hospital - Roskilde
Collaborator
Source ClinicalTrials.gov